<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>42980fbd-a809-4f0e-af79-739fdac90d2c</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-04-27</publicVersionDate><devicePublishDate>2022-04-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>50604351708001</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00604351708006</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>00604351708006</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Nasoneb®</brandName><versionModelNumber>Sinus Therapy System Supply Kit</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>056332380</dunsNumber><companyName>Monaghan Medical Corporation</companyName><deviceCount>1</deviceCount><deviceDescription xsi:nil="true"/><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts><customerContact><phone>518-561-7330</phone><phoneExtension xsi:nil="true"/><email>customerservice@monaghanmed.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44845</gmdnCode><gmdnPTName>Nasal irrigation set, home-use</gmdnPTName><gmdnPTDefinition>A collection of non-sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness); it may also be used to create a solution. It typically includes an irrigation bottle/canister, actuator tips and adaptors for various solution-delivery applications, and sometimes packets of sodium-based solutes or prepared solution. It is intended for use in the home. After application, the solution cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>CAF</productCode><productCodeName>Nebulizer (Direct Patient Interface)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>